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Are There Protective Effects of Antioxidants, Calcium Channel Blocker and Angiotensin Receptor Blocker Against Extracorporeal Shockwaves Lithotripsy Induced Renal Injury? (SWL)

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ClinicalTrials.gov Identifier: NCT01675362
Recruitment Status : Completed
First Posted : August 29, 2012
Last Update Posted : October 9, 2014
Sponsor:
Information provided by (Responsible Party):
Ahmed R. EL-Nahas, Mansoura University

August 27, 2012
August 29, 2012
October 9, 2014
August 2012
August 2014   (Final data collection date for primary outcome measure)
Renal damage [ Time Frame: two hours and one week after Extracorporeal shock wave lithotripsy (ESWL) ]
The protective effect will be evaluated via estimation of the changes in renal tubular enzyme (NGAL) and detection of albumen levels in urine.
Same as current
Complete list of historical versions of study NCT01675362 on ClinicalTrials.gov Archive Site
The mechanisms of renal protection [ Time Frame: Before ESWL, 2 hours and 1 week after ESWL ]
The mechanisms of protection will be investigated by estimation of renal perfusion and functional changes using dynamic MRI
Same as current
Not Provided
Not Provided
 
Are There Protective Effects of Antioxidants, Calcium Channel Blocker and Angiotensin Receptor Blocker Against Extracorporeal Shockwaves Lithotripsy Induced Renal Injury?
A Randomized Controlled Trial for Evaluating Protective Effects of Antioxidants (Selenium and Vitamins A, C and E), Calcium Channel Blocker (Verapamil) and Angiotensin Receptor Blocker (Losartan) Against Extracorporeal Shockwaves Lithotripsy Induced Renal Injury
This study will be conducted to evaluate the protective effects and mechanisms of antioxidants (vitamins A, C, E and Selenium), calcium channel blocker (Verapamil) and angiotensin receptor blocker (Lozartan) against shock wave induced renal injuries.
The protective effect will be evaluated via estimation of the changes in renal tubular enzyme (NGAL) and detection of albumen levels in urine. The mechanisms of protection will be investigated by estimation of renal perfusion and functional changes using dynamic MRI.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Kidney Calculi
  • Drug: Antioxidant group
    They will be receive vitamins A, C, E and selenium (Selenium ACE) Dosage: Two tablets before ESWL Then 2 tablets every 8 hours after ESWL for one week
    Other Name: Selenium ACE
  • Drug: Calcium Channel Blockers
    They will receive Verapamil (Isoptin 80 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every 12 hours after ESWL for one week
    Other Name: Verapamil
  • Drug: Angiotensin receptor blocker group
    They will receive Losartan (Cozaar 50 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every day after ESWL for one week
    Other Name: Losartan
  • Drug: Placebo
    They will receive placebo
  • Placebo Comparator: Control group
    They will receive placebo
    Intervention: Drug: Placebo
  • Active Comparator: Antioxidant group
    They will be receive vitamins A, C, E and selenium (Selenium ACE) Dosage: Two tablets before ESWL Then 2 tablets every 8 hours after ESWL for one week
    Intervention: Drug: Antioxidant group
  • Active Comparator: Calcium channel Blockers
    They will receive Verapamil (Isoptin 80 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every 12 hours after ESWL for one week
    Intervention: Drug: Calcium Channel Blockers
  • Active Comparator: Angiotensin receptor blocker group
    They will receive Losartan (Cozaar 50 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every day after ESWL for one week
    Intervention: Drug: Angiotensin receptor blocker group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
Same as current
October 2014
August 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Well functioning kidney (serum creatinine <1.2 mg/dl).
  2. Solitary renal stone.
  3. Size: 25 mm or less in the largest diameter.

Exclusion Criteria:

  1. Contraindications to ESWL
  2. Previous surgical treatment of renal stones.
  3. Congenital renal anomalies.
  4. Pediatric patients (age <18 years).
  5. Patients with Diabetes or hypertension
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
 
NCT01675362
4228
Yes
Not Provided
Not Provided
Ahmed R. EL-Nahas, Mansoura University
Mansoura University
Not Provided
Principal Investigator: Ahmed R. EL-Nahas, MD Mansoura University
Mansoura University
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP